“Computer Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)
Title:
“Computer Crossmatch”
(Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm252894.pdf
Document Type:
Guidance for Industry
Content:
This guidance describes certain of the practices that FDA, believes satisfy the requirements in 21 CFR 606.151 to help ensure detection of an incompatible crossmatch when using an electronic based system for matching a donor's cell type with a recipient's serum or plasma type